Strategic Validation & Compliance Lead

SRG; Stirling; On-site; GBP 65,000 - 90,000; Full time

Job summary

SRG is seeking a Senior Qualification & Validation (Q&V) Specialist for a global pharmaceutical manufacturer with a GMP-regulated site in Central Scotland. You will own key Q&V quality system elements, coordinate validation projects and maintain compliance with UK/EU/US GMP/GDP, ICH, ISPE and other requirements.

You will lead validation documentation, support protocol execution and Periodic Review activities, and develop training packages while staying current with regulatory expectations and

Qualifications

• Technical or scientific qualification relevant to the role or equivalent practical experience.
• Strong technical knowledge of qualification and validation systems.
• Excellent written and verbal communication skills.
• Experience supporting audits and regulatory inspections.
• Ability to plan, coordinate and deliver validation projects.

Responsibilities

• Provide planning, support and guidance for validation projects and SOPs.
• Oversee project plans and milestones to meet compliance.
• Coordinate resourcing and facilitate validation projects across the site.
• Provide validation expertise, advice and guidance to the site, the Q&V team and third parties.
• Develop validation documentation and facilitate review and approval of validation documents.
• Offer practical support during protocol execution and reporting.
• Provide oversight, metric reporting and practical support for Periodic Review activities.
• Manage the SVMP Inventory and SVMP Schedule using information from validation practitioners.
• Develop and deliver training packages on validation-related topics.
• Maintain up-to-date knowledge of regulatory expectations and industry best practice in validation.

Skills

Qualification systems

Validation processes

Documentation skills

Communication skills

Training delivery

Project planning

Audits & inspections

Team collaboration

Education

Science/technical degree

Tools

Computer systems

Job description

SRG is seeking a Senior Qualification & Validation (Q&V) Specialist for a global pharmaceutical manufacturer with a GMP-regulated site in Central Scotland. You will own key Q&V quality system elements, coordinate validation projects and maintain compliance with UK/EU/US GMP/GDP, ICH, ISPE and other requirements.

You will lead validation documentation, support protocol execution and Periodic Review activities, and develop training packages while staying current with regulatory expectations and